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Diabetes drug Avandia comes under new criticism

July 25, 2009 | 10:15 am

The diabetes drug rosiglitazone, already under fire because it has been found to increase the risk of heart attacks, can also produce liver failure and death in some patients, researchers from the activist group Public Citizen said this week.

They wrote in the journal Pharmacoepidemiology and Drug Safety that a review of adverse events reported to the Food and Drug Administration found 11 deaths due to liver toxicity between 1997 and 2006 associated with the drug, which is sold under the brand name Avandia. The group had petitioned the FDA in October to ban the drug because of the heart risks, and they renewed their call for action.

"Because of low reporting rates to the [FDA] database, the 11 cases likely represent a small fraction of the patients who developed liver failure because of the drug," said Dr. James Floyd of Public Citizen. He estimated that 1 in every 44,000 patients who take the drug develops liver failure.

Previous studies have shown that Avandia increases the risk of heart attack by about 40%, doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss from macular edema, a swelling of the retina caused by the accumulation of fluids in the eye, according to Public Citizen. Reports of the drug's risk have sharply reduced prescriptions for it: They dropped from a peak of about 13.2 million in 2006 to 3.1 million in 2008. That means that 8,500 prescriptions for the drug are still filled every day.

The group also found 10 deaths from liver failure associated with the related drug pioglitazone, sold under the brand name Actos. That drug has not been linked to heart attacks, but is associated with an increased risk of heart failure, Floyd said. Public Citizen estimated 1 case of liver failure for every 52,000 patients taking it.

The manufacturers of both drugs contend that no scientific study has linked them to liver toxicity. Public Citizen, however, recommends that patients should stick to older and safer -- and, not incidentally, cheaper -- medications like metformin (Glucophage) and glipizide (Glucotrol).

-- Thomas H. Maugh II

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Comments (4)

It is All About the Money!!! I took Avandia from 6-03 to 1-06- While taking Avandia I lost my vision from 20/20 to 20/400. I had a Stint put in my Heart 3-06. I had Open Heart bypass surgery 8-07 & Balloone surgery on my heart 7-09.The F D A has been a Joke. G S K is ONLY concern about Profit, Money!! The Senators & Congressman are only worried about getting Big Bucks from Big Pharma to stay in office. The Lawyers will say O, you have a case, then it is all dropped-Wonder Why???? Avandia has harmed so so many yet it is still on the market. Someone Please Help--
Pat Kelly
25475 Humphries Circle
Claremore OK 74019
PH & Fax 918-379-0198

Poor Avandia is getting more bad publicity. But then we need this kind of publicity so we can evaluate our treatment plan and be able to make changes. What gets me is that if Avandia has been implicated in heart attacks and now in liver toxicity, how come it is still in the market?

Evelyn Guzman
http://www.free-symptoms-of-diabetes-alert.com (If you want to visit, just click but if it doesn’t work, copy and paste it onto your browser.)

Here is some good information on the issue of Avandia side effects: Group Says Avandia Ups Risk For Liver Damage: http://www.newsinferno.com/archives/10125#more-10125

In Canada, they are telling people-Do not take Avandia. Other safer drugs are out their
In the U S A, It is All About the Money!!! I took Avandia from 6-03 to 1-06- While taking Avandia I lost my vision from 20/20 to 20/400. I had a Stint put in my Heart 3-06. I had Open Heart bypass surgery 8-07 & Balloone surgery on my heart 7-09.The F D A has been a Joke. G S K is ONLY concern about Profit, Money!! The Senators & Congressman are only worried about getting Big Bucks from Big Pharma to stay in office. The Lawyers will say O, you have a case, then it is all dropped-Wonder Why???? Avandia has harmed so so many yet it is still on the market. Someone Please Help--
Pat Kelly
25475 Humphries Circle
Claremore OK 74019
PH & Fax 918-379-0198



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